Fed Circuit opens door for additional pharma revenues in Supernus decision
The US Court of Appeals for the Federal Circuit has overturned a reduction in the patent term adjustment (PTA) owned by Supernus Pharmaceuticals.
The Federal Circuit ruled that the US Patent and Trademark Office (USPTO) had exceeded its statutory authority and miscalculated the appropriate patent term adjustment.
Matt Gibson, partner at Reed Smith in Houston, said that the ruling could lead to “millions of dollars for branded pharmaceutical companies in additional patent exclusivity as a result of the adjustment of patent terms that may arise from this decision”.
Supernus registered its patent for an “osmotic drug delivery system” (US number 8,747,897) in 2014.
The company originally applied for the patent in 2006. In February 2011, Supernus submitted a request for continued examination (RCE) to the USPTO after the office initially rejected the application.
In 2011, the European Patent Office granted a European patent to Supernus (number 2010189). After that, German pharmaceutical company Sandoz filed an opposition to the European patent in August 2012.
Supernus supplied an information disclosure notice (IDS) to the USPTO in November of that year, informing the office of the Sandoz opposition.
Upon granting the patent in 2014, the USPTO issued a PTA of 1260 days in addition to the patent’s standard 20-year term.
This was calculated based on USPTO delays in examining the patent in accordance with statutory deadlines. The USPTO also factored into the PTA a reduction of 646 days attributed to Supernus’ delays in advancing the patent application between filing the RCE in February 2011 and issuing the IDS in November 2012.
Supernus conceded 100 days of that period as attributable to its own delays, but argued that there was no action it could have taken to advance proceedings for the remaining 546 days.
The USPTO rejected a Supernus request to reconsider its decision to reduce the PTA by 646 days. In 2016, the US District Court for the Eastern District of Virginia affirmed the USPTO’s decision after an appeal from the pharmaceutical company.
Supernus filed another appeal, to the Federal Circuit, in 2017.
In its ruling, issued January 23, the Federal Circuit found that there was “no action Supernus could have taken to advance prosecution of the patent during the 546-day period, particularly because the EPO notice of opposition did not yet exist”.
“Congress intended that the PTA statute not adversely impact applicants like Supernus who could have done nothing to advance prosecution”, the ruling said.
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